Kornimate/medical-research-clean huggingface dataset:
study of how the dose of dialysis is affected by dialysate flow rate

Conditions: Chronic Kidney Disease; Chronic Renal Disease

Summary: the purpose of this study is to look at how the dose of dialysis is affected by the rate at which dialysate flows through the dialyzer. the dose of dialysis (kt/v) will be determined by measuring blood levels of urea at the beginning and end of dialysis at two different dialysate flow rates.


Eligibility criteria:
inclusion criteria: * adult subject ≥18 years of age undergoing chronic hemodialysis for end- stage renal disease (esrd) three times a week for at least three months with a stable treatment prescription * subject has no hospitalizations in previous three months for a significant illness related to a renal or dialysis problem except for vascular access surgery * subject with an av fistula or graft capable of routinely delivering a blood flow rate of 400 ml/min exclusion criteria: * subject who is non-compliant with dialysis prescription * subject whose hemodialysis schedule is not three times a week * subject using a catheter for blood access * subject who is not anticoagulated with heparin during hemodialysis * subject with a current malignancy involving sites other than skin * subject with a history of drug or alcohol abuse within the last six months * subject who is believed to be unable to complete the entire study (e.g., due to a concurrent disease, life expectancy of less than a year, or scheduled kidney transplant * subject who is pregnant * subject who is considered incompetent to give an informed consent * subject with a positive test for hepatitis b surface antigen within the past 30 days (testing for hepatitis b surface antigen is not required for subjects who have tested positive for hepatitis b antibody within the past year and any such patients will not be subject to this exclusion criterion) * subject with known hiv infection (if this is not known, no hiv testing will be performed

Keywords: hemodialysis dialysis, renal
dexmedetomidine, ketamine and magnesium sulphate in caudal block for hypospadias repair

Conditions: Preemptive Analgesia; Dexmedetomidine; Ketamine; Magnesium Sulphate; Hypospadias; Pediatrics

Summary: caudal epidural block is a rapid, reliable, and safe technique that can be used with general anesthesia for intraoperative and postoperative analgesia in pediatric patients ketamine is a selective antagonist of n-methyl-d-aspartate (nmda) receptor, an ionotropic glutamate receptor.


Eligibility criteria:
inclusion criteria: * aged 1-7 years * american society of anesthesiologists (asa) classification i and ii, undergoing hypospadias repair. exclusion criteria: * developmental delay * psychological or neurological disorders * difficult airway * hyperactive airway disease or children in whom caudal block was contraindicated (e.g., infection at the site of block, bleeding disorder, or abnormalities of the sacrum).
vitamin d supplementation and varicella zoster virus vaccine responsiveness in older long-term care residents

Conditions: Immunosenescence; Shingles

Summary: this is an ancillary study to a randomized controlled trial of high dose vitamin d in older long-term care residents (nct01102374). in this study, a subset of trial subjects will receive the zoster vaccine and the investigators will determine the immunological response to the vaccine in this older, frail population, as well as the association between vitamin d and immunological outcomes.

objectives 1. to determine the increase in varicella-zoster virus (vzv)-specific cell-mediated immune response from pre-zoster vaccination to 3 weeks post-vaccination in nursing home residents after 4 months of high dose vs. standard dose vitamin d3 supplementation. 2. in the same participants as aim 1, to measure the association between pre-zoster vaccination 25-hydroxyvitamin d \[25(oh)d\] levels and the increase in vzv-specific cell-mediated immune response from pre- vaccination to 3 weeks post-vaccination. 3. characterize the phenotypic and functional vzv-specific t cell responses to zostavax, including memory, effector, th1/th2, and homing receptor-bearing t cells in the high compared to low elispot responders. hypotheses 1. at baseline, higher serum 25(oh)d levels will be associated with higher levels of vzv-specific cell-mediated immunity (cross-sectional). 2. at baseline, higher serum 25(oh)d levels, independent of vitamin d supplementation dose, will be associated with greater increases in vzv-specific cell-mediated immune responses to zostavax, as measured by the interferon (ifn)-γ elispot assay. 3. compared to standard dose, high dose vitamin d3 supplementation will enhance vzv-specific cell-mediated immune response to vaccination independent of baseline serum 25(oh)d levels.

Eligibility criteria:
inclusion criteria: 1. aged ≥ 60 years; 2. residing in a long-term care facility; 3. have not yet received vzv vaccine exclusion criteria: 1. terminal illness (expected survival \<6 months); 2. anticipated discharge within 12 months; 3. unable to take whole or crushed tablets; 4. active cancer, except squamous/basal cell carcinoma; 5. severe malnutrition (body mass index \<18 kg/m2); 6. current immunosuppressive medications (including corticosteroids); 7. renal failure (egfr\<15 ml/min/1.73m2); 8. currently taking \>800 iu/d vitamin d supplementation; 9. history (or strong family history) of kidney stones; 10. history of sarcoidosis or other granulomatous disorders associated with hypercalcemia; 11. elevated baseline hypercalcemia (albumin-adjusted serum calcium \>10.5 mg/dl); 12. serum 25 (oh)d level ≥40 ngl/ml at baseline; 13. inability to provide informed consent and no available healthcare proxy; 14. inability of participant or proxy to speak/understand english. 15. previous receipt of the zostavax (anticipate \<10% of trial; 16. known allergy to gelatin, neomycin, or any other component of the vaccine.

Keywords: immunosenescence shingles vitamin d varicella zoster virus vaccine immune response geriatrics
the pressure cabg cardiac surgery trial

Conditions: Coronary Artery Bypass Grafting; Hypotension

Summary: this study will be a pragmatic, prospective, single-centre, unit-based cluster crossover, open-label registry trial. the cardiac surgical intensive care unit (csicu) will be cluster assigned to alternating map targets in 6-month blocks in a sequence. additional sites across alberta may be added, as necessary.

personalized arm: the target map will be defined as +10% of the resting map. resting map will be defined in priority order using one of the following map measurements: * pre-operative anesthesia or surgical consultation; * other physician outpatient consultation (e.g. cardiology, family physician, internist) within 30 days of surgery; * inpatient measurement the night before surgery; * pre-anesthetic map the lower and upper safety limits of personalized map targets will be 50mmhg and \<90mmhg, respectively. protocolized arm: the target map will be defined as 65 +/- 5mmhg. pharmacologic and fluid treatment decisions will be at the discretion of the most responsible physician. in both study arms, the blood pressure control period will extend from anesthetic induction until 12 hours after admission to the csicu. as an additional safety metric, the anesthesiologist will be encouraged to utilize clinically-driven cerebral saturation monitoring to identify potential hypoperfusion. in cases with low bilateral saturations where the anesthesiologist feels low map may be the putative mechanism, the investigators will request that maps be raised in 5mmhg increments. following completion of the study protocol, the map and/or systolic blood pressure targets will be at the discretion of the most responsible physician.

Eligibility criteria:
inclusion criteria: * all patients \> or = to 18 years of age undergoing non-emergent cabg exclusion criteria: * pre-induction use of intravenous inotrope, vasopressor, or vasodilator * re-operation during the index hospital stay * non-cabg valvular or aortic surgery * \*patients with end-stage renal disease or pre-operative aki (defined as in-hospital increase in creatinine by \>50%) will be excluded from the renal outcomes but included in the analysis of secondary outcomes
exposure to virtual reality as psychosocial intervention in colorectal cancer surgery

Conditions: Anxiety; Colorectal Cancer

Summary: a prospective controlled randomized interventional study comparing the effects of the preoperative exposure to a virtual reality software versus not exposure in 126 patients with colorectal cancer. patients will be divided in two randomized groups, each of them of 63 patients. the hypothesis of the study is that gradual exposure to the hospital environment using a virtual reality software is effective to reduce preoperative anxiety. the main variable is the level of anxiety in patients undergoing colorectal cancer surgery. it will be measured using state-trait anxiety inventory scale (stai-s) and the hospital anxiety and depression scale (hads).

colorectal cancer is the third most frequent neoplasia diagnosed worldwide, and in spain it is the first in incidence and prevalence, accounting for 15% of all neoplasias according to world health organization (who). the incidence of preoperative anxiety in patients undergoing elective surgery is high (60% - 76%). there are many causes for this: anticipation of postoperative pain, loss of independence, separation from the family, fear to the surgical procedure or to severe complications or even death. the incidence of preoperative anxiety varies according to age, sex, educational leve, previous exposure to surgical interventions and the expected impact of the surgical procedure in global quality of life. patients with anxiety require higher dosis of induction anesthesia, longer hospital stay, and a higher rate of perioperative complications due to a release of catecholamines, increase on the oxidative demands, causing tachycardia, arrhythmia, high blood pressure, etc. gradual exposition is considered an effective way of reducing anxiety. it has been demonstrated that anxiety is decreased in patients with history of surgical interventions, and thus the experience is experimented as an adaptive process. virtual reality gives the opportunity to experience each of the steps of the hospital stay in a realistic environment. the hypothesis of this study is that gradual exposure to the hospital environment using virtual reality is an effective tool to reduce preoperative anxiety in patients undergoing colorectal cancer surgery.

Eligibility criteria:
inclusion criteria: * diagnosed of colorectal cancer requiring elective surgery. * american society of anesthesiologists (asa) i - iii. * no surgical history. * surgical procedure programmed in the next 6 months. exclusion criteria: * neurologic deficits. * visual disorder. * neuro-psychiatric disorder. * use of neuro-psychiatric drugs. * non-sphincter-preserving surgery.

Keywords: virtual reality (vr) anxiety colorectal cancer surgery
safety, pharmacokinetics, pharmacodynamics, and clinical activity study in vlbw neonates of bsyx-a110

Conditions: Staphylococcal Sepsis

Summary: the purpose of this study is to evaluate the safety (including tolerability), pharmacokinetics, pharmacodynamics and clinical activity of bsyx-a110 administered in a 3-dose regimen on study days 0, 7, and 14.

this phase ii study will be a randomized, double blind, placebo controlled study of bsyx-a110 in very low birth weight neonates. a total of 80 infants will be dosed in this study. participants will receive either bsyx-a110 or placebo, at 60 mg/kg or 90 mg/kg. the study drug will be administered at 48-120 hours of life, 7 days after the initial dose, and 14 days after the initial dose for all dose groups.

Eligibility criteria:
inclusion criteria: patients must meet all of the following criteria at the time of first infusion (day 0): 1. 48-120 hours of age, inclusive 2. birth weight of 700-1300 grams 3. inpatient in a neonatal intensive care unit 4. written informed consent obtained from the parent(s) or legal guardian multiple gestations: 1. siblings from multiple gestations may be enrolled if they each meet the entry criteria 2. no more than 4 subjects in any birth weight cohort may be siblings exclusion criteria: patients may have none of the following at the first dose: 1. survival not expected for at least 1 week after infusion 2. clinically overt systemic infection, as determined by history, physical examination, and positive culture from a normally sterile site. (infuse only when infant clinically stable and cultures negative for 48 hours. if being evaluated for sepsis, decision to infuse may be deferred as allowed by protocol infusion window. infusions outside of protocol window must be approved by sponsor.) 3. severe congenital anomalies or genetic disorders that are likely to be fatal or that may interfere with drug distribution or metabolism, as determined by history and/or physical examination, and including but not limited to: i. trisomy 13 ii. trisomy 18 iii. hypoplastic left heart syndrome iv. omphalocele v. gastroschesis vi. holoprosencephaly 4. known or suspected hepatic or renal insufficiency 5. clinically uncontrolled seizures 6. immunodeficiency other than due to prematurity 7. a history of standard immune globulin administration prior to first study drug infusion (excluding hepatitis b immune globulin, hbig) 8. any history, in the infant subject or its mother, of a hypersensitivity or severe vasomotor reaction to immunoglobulin g, or blood products 9. currently receiving, recently received, or planned to receive other investigational agents that could interfere with conduct or results of this study; including enrollment in another investigational study for a product under an irb-approved protocol 10. expectation that the patient will not be able to be followed for the duration of the study 11. mother with serology positive for hepatitis b surface antigen

Keywords: staphylococcal monoclonal antibodies very low birth weight infants prophylaxis
using a cold atmospheric plasma device to treat skin disorders

Conditions: Actinic Keratosis; Acne/Rosacea; Verruca Plana; Tinea; Molluscum Contagiosum; Bowen's Disease; Warts

Summary: this study examines the efficacy of a non-thermal, atmospheric plasma device in the treatment of skin disorders

the study uses non-thermal atmospheric pressure plasma to treat target conditions. the patients are monitored at set intervals for efficacy and adverse effects using investigator's assessment and imaging techniques

Eligibility criteria:
inclusion criteria: * diagnoses of target conditions * ability to complete study protocol exclusion criteria: * based on specific condition
mrs and dti of white matter in alzheimer's disease

Conditions: Alzheimer's Disease; Vascular Dementia

Summary: the white matter change of the alzheimer's disease could be studied by diffusion tensor image and mr spectroscopy to see the microstructral and biochemical change.


Eligibility criteria:
inclusion criteria: * probable alzheimer's disease or subcortica type vascular dementia exclusion criteria: * large vessel infarct, major trauma

Keywords: diffusion tensor imaging mr spectroscopy dementia white matter
oral adherence in hematological oncology agents and impact on comorbid therapy adherence

Conditions: Chronic Myeloid Leukemia; Chronic Lymphocytic Leukemia; Multiple Myeloma; Multiple Chronic Conditions

Summary: the objective of this study is to improve medication, symptom, and disease management of patients with hematological malignancies and multiple chronic conditions (2 or more conditions in addition to cancer) through care coordination between pharmacists working in oncology practices and those working in primary care or community practices (pharmacists coordinated care oncology model \[pcom\]). this is a pilot study in which the investigators will examine the association between outcome measures, but the study design and sample size are insufficient to quantify the impact of oaa initiation or oaa adherence on adherence to chronic medications. this pilot study and data analyses are being done in preparation for a larger, controlled study.


Eligibility criteria:
inclusion criteria: * receiving cancer care at vanderbilt university medical center * diagnosis of chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll), chronic myeloid leukemia (cml), or multiple myeloma (mm) * initiating an oral anticancer agent, either for the first time or a change from previous oral agent * diagnosis of 2 chronic conditions, including at least one of the following: diabetes, hypertension, hyperlipidemia, congestive heart failure, depression/anxiety, gastroesophageal reflux disease, and/or chronic obstructive pulmonary disease * patients taking at least two chronic medications, including at least one medication for one of the conditions listed above. * willing and able to sign informed consent. exclusion criteria: * cannot communicate in english * concurrent diagnosis of type 1 diabetes or human immunodeficiency virus

Keywords: adherence leukemia anticancer agents chronic disease management pharmacy practice hematological malignancy
safety and efficacy of oral lpcn 1021 in men with low testosterone or hypogonadism

Conditions: Male Hypogonadism

Summary: the purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.


Eligibility criteria:
inclusion criteria: 1. documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired). 2. serum total testosterone \< 300 ng/dl based on 2 consecutive blood samples exclusion criteria: a subject will not be eligible for study participation if he meets any of the following criteria. 1. history of significant sensitivity or allergy to androgens, castor oil or product excipients. 2. clinically significant findings in the prestudy examinations. 3. abnormal prostate digital rectal examination (dre) with palpable nodule(s) or i-pss score \> 19 points. 4. body mass index (bmi) ≥ 38 kg/m2. 5. clinically significant abnormal laboratory values 6. positive test result for hepatitis a virus immunoglobulin m (hav-igm), hepatitis b surface antigen (hbsag) or hepatitis c virus antibody (hcv ab) or human immunodeficiency virus antibodies (hiv ab). 7. history of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures. 8. history of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, ph or absorption. 9. history of any clinically significant illness, infection, or surgical procedure within 1 month prior to study drug administration. 10. history of stroke or myocardial infarction within the past 5 years. 11. history of, or current or suspected, prostate or breast cancer. 12. history of diagnosed, severe, untreated, obstructive sleep apnea. 13. history of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years. 14. history of long qt syndrome or unexplained sudden death in a first degree relative (parent, sibling, or child). 15. concurrent treatment with medications which may impact the absorption, distribution, metabolism or excretion of testosterone undecanoate (tu) or place the subject at risk for treatment with testosterone. 16. subject has a partner who is currently pregnant or planning pregnancy during the course of the clinical trial.

Keywords: testosterone male hypogonadism low testosterone lpcn 1021 androgel testim testopel fortesta axiron. hypogonadism eunuchism gonadal disorders endocrine system diseases testosterone enanthate testosterone undecanoate testosterone 17 beta-cypionate methyltestosterone androgens hormones hormones, hormone substitutes, and hormone antagonists physiological effects of drugs pharmacologic actions antineoplastic agents, hormonal antineoplastic agents anabolic agents
amplatzer duct occluder ii clinical study

Conditions: Patent Ductus Arteriosus

Summary: the objective of this study is to investigate the safety and effectiveness of the ado ii in patients with a pda.


Eligibility criteria:
inclusion criteria: * subject must have diagnosis of a pda * subject must have a pda \< 5.5mm in diameter by angiography * subject must have a pda \< 12mm in length by angiography * subject must have a pda \> 3mm in length by angiography * subject/legally authorized representative must give consent to participate in the clinical study * subject/legally authorized representative must consent to follow-up for the duration of the clinical study exclusion criteria: * subject must not be \< 6 kilograms for the procedure * subject must not be \< 6 months of age * subject must not be ≥ 18 years of age * subject must not have a descending aorta \< 10mm in diameter * subject must not have a right to left shunt through the patent ductus arteriosus * subject must not have pvr above 8 woods units or a rp/rs \>0.4 * subject must not have intracardiac thrombus * subject must not have additional cardiac anomalies requiring surgical or interventional correction * subject must not have history of more than two lower respiratory infections within the last year (i.e., pneumonia) * subject must not have active infection requiring treatment at the time of implant * subject must not have contraindication to anticoagulation treatment * female subjects of child bearing age must not be pregnant or desire to become pregnant within six months post implant\* * subject must not be participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints * if the subject desires to become pregnant after six months post-implant, further restriction is at the discretion of their physician.

Keywords: patent ductus arteriosus pda